BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II CATHETER

    MDR report key: 1739804 · Received June 14, 2010

    Report

    Report Number
    1318694-2010-00005
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    April 21, 2010
    Report Date
    June 14, 2010
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K003052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A CATHETER WAS PULLED FROM INVENTORY AND BENCH TESTING WAS PERFORMED. THE CATHETER HAS A LABELED RATED BURST PRESSURE OF 2.0 ATM AND A LABELED NOMINAL PRESSURE OF 1.5 ATM. THE COMPARATIVE CATHETER FROM THE SAME LOT BURST AT 3.5 ATM DURING THE BENCH TESTING. IT IS UNKNOWN WHETHER OR NOT AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED AS RECOMMENDED IN THE INSTRUCTIONS FOR USE. THE PHYSICIAN STATED THAT HE CONSIDERED THE PROCEDURE A SUCCESS AND DID NOT HAVE ANY ISSUES WITH THE CATHETER. THEY DO NOT BELIEVE IT TO BE DEVICE RELATED, BUT RATHER A CLOT THAT WAS DISLODGED THAT CAUSED THE STROKE AND SUBSEQUENT DEATH.

    Description of Event or Problem · 1

    PATIENT EXPIRED THE DAY AFTER A BALLOON VALVULOPLASTY PROCEDURE WAS PERFORMED USING A TYSHAK II BALLOON CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II CATHETER PTV CATHETER LIT NUMED, INC. 105 TT-6463

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death